safety and efficacy of lotemax versus fml in subjects undergoing prk for the correction of mild to moderate myopia, 3- month follow-up study

Conditions: Must be PRK Candidate

Summary: study objective: to evaluate and compare the safety and efficacy of (corneal wound healing and intraocular pressure) fluorometholone and loteprednol after photorefractive keratectomy (prk) surgery. overall study design: structure: single-center, randomized, single blinded, contralateral (one eye receives fml, one eye lotemax) treatment group: patients will be randomized to the eye and will receive fml in one eye, lotemax in contralateral eye duration: 3 months dosage/dose regimen: all patients will receive each one of the steroid agents 4 x a day for one month, 3 x a day for one month and 2 x a day for one month study medication will be administered to the randomized eye through post op days according to mention protocol. visit schedule: baseline-screening, postop days 1, 7, 30 and then month 3th (through corneal re-epithelialization).


Eligibility criteria:
inclusion criteria: * male or female patients, 18-45 yrs of age, in good general health * prk candidate(subjects willing and able to undergo bilateral prk for the correction of their myopia. ) * refractive error -1 to -8 diopters (spherical equivalent) at baseline * females of childbearing age must have a negative pregnancy test result at baseline. a female considered to be of non-childbearing potential is she is postmenopausal (no menses for 12 consecutive months) or is without a uterus. * ability to follow study instructions and likely to complete the entire course of the study(subjects who are able to comply with all study procedures, including wearing a soft bandage contact lens in the immediate postoperative period. ) * written informed consent will be obtained * written hippa authorization will be obtained * subjects with mrse \<6.0 d, with less than 2.0 d of astigmatism. * stable prescription in both eyes as defined by \<0.25 d change over the preceding 2 years. exclusion criteria: * uncontrolled systemic disease you mean if someone has controlled dm or rheumatic disease can be included * any active ocular disease, corneal abnormalities, lid abnormalities, or any ocular pathologies * history of serious eye disease, trauma, or previous ocular surgery * history of unstable myopia * history of herpes keratitis * known allergy or hypersensitivity to the study medication * anticipated wearing of contact lenses in addition to the required bandage contact lens post-prk. patients who wear soft contact lenses should discontinue wearing them at least 7 days prior to baseline visit. patients wearing rgp or hard contact lenses should discontinue wearing them at least 3 weeks prior to baseline visit. * females who are pregnant, breastfeeding, or trying to conceive. * keratoconus or keratoconus suspect * any condition or situation which, in the investigator's opinion, may put patient at significant risk or may confound the study results * subjects who have a past or present disease, which as judged by the investigator may affect the safety of the subject or the outcome of the study. * subjects who have previously had corneal surgery. * subjects with any ocular disease or corneal abnormality, including but not limited to: * decreased corneal sensation / neurotrophic cornea; * corneal vascularization; * keratoconus; * keratoconjunctivitis sicca requiring chronic treatment; * lagophthalmos; * blepharitis; * history of infectious keratitis; * history of glaucoma or intraocular pressure of \>21 mmhg or use of glaucoma medications; * significant dry eye disease that requires regular topical treatment; * corneal thickness \<480 µm at the thinnest point, and * posterior elevation \>40 micron. * subjects who require any topical ophthalmic medication other than the pre- and postoperative regimen defined in the study protocol. * subjects who are taking amiodarone, long acting anticholinergics, e.g., atropine, scopolamine, or medications or agents that can cause dry eye.